Answer Posted / kala

HPLC is a nondestructive method,gc is destructive

If change in specification which parameter require to do for validation? if change in chromtographic condition then which parameter? if api change then which parameter? if change composition then which parameter? if old method not work out then whicj parameter? if additional one impurity added then which parameter of validation require to do on above each conditions? elaborate separately

906

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iam usig ph buffers merk. manually how to prepare ?

2327

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we are performed SOR for a particular product the limit is -6 to -10.We face particular bathes it is not meeting the specification.we performed diffrent instrument diffrent analyst we are getting diffrent diffrent results.solvent is dimethyl sulfoxide what could be the reasion

1919

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In HPLC (Waters) software Empower1,2 &3 what is the updation for each version

3084

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In the HPLC Calibration done wavelength accuracy done between 200nm-280nm .but not done remaining 300-400nm not done ?

974

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Which products will produce when acetic anhydride reacts with Ter-butanol, Sec-butanol, Iso butanol, Dimethylamine etc.

2911

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How we can identify process related and degradation impurity in single method with short period?

867

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what is turbidimetric titration?Give 2 examples.

2733

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What is the diference between residual solvents and organic volatile matter

2109

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Ratio of Water and Acetonitrile(diluent) is not recommended to use in cleaning method validation,why?

3024

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how to develop the icp ms method? Application of icp ms?

848

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How to know the estimated LOQ concentration in ppm

1277

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How can the GC or HPLC method is selected to determine the impurity profile in drug product?

7676

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While performing TOC sst analysis Zero shift disabled & sample analysis zero shift enabled why?

2901

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Why do we use KMnO4 in the test of control of obsorbance ? and why do we take specific quantity i.e 57-63mg?

2889

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